Fertility Study of Women Who Received Organ Transplantation

NCT03455062 | Completed

• 2 other identifiers: RC31/17/00922017-A00913-50
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In terms of immunity, pregnancy can be considered a semi-allogeneic transplant. There are several immunological mechanisms for implantation and maintenance of pregnancy by induction of tolerance without induction of immunosuppression. This study wants to evaluate the impact of immunodepression on women's fertility by studying the fertility of transplanted cardiac, renal, hepatic and pulmonary women.

Conditions

Transplant; Fertility

Keywords

Transplant, fertility

Outcome Measures

Primary Outcomes (1)

• Birth rate

  Birth rate after spontaneous or induced pregnancy in women with heart, kidney, liver, pancreatic or pulmonary transplantation

  1 day

Secondary Outcomes (2)

• Rates of ectopic pregnancy

  1 day

• Rates of desire of pregnancy

  1 day

Interventions

Questionnaire about fertility OTHER

Recruitment of participants through the list of cardiac, renal, hepatic, pancreatic or pulmonary transplant patients collected from the the Organ Transplant Unit. A letter from the the Organ Transplant Unit will initially be sent to patients informing them of the study and if they do not wish to participate they can report their opposition by email. A fertility questionnaire will be send and that will have to be returned by the patient in order to be included in the study. The questionnaires, anonymous, will be numbered according to their order of return.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Principal outcome is about the fertility and the pregancy rate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Living patients who had a transplant before age 40

You may qualify if:

• Major patient
• Patient who has had a heart, kidney, liver, pancreatic or pulmonary transplant for at least 5 years
• Patients under 40 at the time of transplant
• Patient having given her no opposition to her participation in research

You may not qualify if:

• Minor patients
• Patients over 40 at the time of the transplant
• Menopausal patients during organ transplantation

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

Location

Study Officials

• Jean Parinaud, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 6, 2018
• Study Start: September 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: March 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)